Cost of FDA Registration
The cost of FDA registration varies with the type of products and FDA classification; there are two costs involved in the FDA registration process. FDA fees and consultant or US FDA Agent fees; if you want to list a product that requires FDA clearance or approval (e.g., a medical device comes under 510k or PMA classification or a drug comes under marketing category NDA or ANDA), you need to add the cost of FDA review or approval program also.
There are no FDA fees for a food facility, but all foreign facilities must have a US FDA Agent. Usually, the agent will be a third party, and the facility needs to pay for their service. LMG fees for US FDA Agent service are $349/year, including a free certificate of FDA registration.
FDA Registration fees incurred in medical device registration, FDA fees for the year 2023 is $6,493; FDA fees will vary each year. LMG fees for US FDA Agent service for a medical device establishment is $449/Year, and listing fees are $50/device. Please visit the FDA Fees page to see the device clearance or approval fees.
There is a fee for OTC Monograph drug manufacturing facility registration. FDA OTC Monograph Drug registration fee for the year 2023 is USD 26,153 for MDF Facility and USD 17,435 for CMO Facility. There are no FDA fees for other types of drug establishment registration. LMG fees for drug establishment registration and us agent service are $649/year; Our fee for drug listing is $399/listing. If your drug comes under the marketing category NDA or ANDA, there are FDA review fees.
Dietary supplements come under food regulations; the fees are the same as food facilities. LMG fees for dietary supplement facility registration and FDA agent service are $349/year.
FDA does not issue a registration certificate, but as your US Agent, LMG will issue a registration certificate after completing FDA registration. You can use this certificate as proof of FDA registration for your customers and industry.